CLARITHROMYCIN tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)

Dostupno od:

Sandoz Inc

INN (International ime):

CLARITHROMYCIN

Sastav:

CLARITHROMYCIN 250 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [see Indications and Usage (1.9)] . Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [see Indications and Usage (1.9)] . Clarithromycin tablets are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococ

Proizvod sažetak:

Clarithromycin tablets, USP 250 mg are white, oval-shaped, film-coated tablets, debossed GG C6 on one side and plain on the reverse side, and are supplied as follows: NDC 0781-1961-60 in bottles of 60 tablets Clarithromycin tablets, USP 500 mg are white, oval-shaped, film-coated tablets, debossed GG C9 on one side and plain on the reverse side, and are supplied as follows: NDC 0781-1962-60 in bottles of 60 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as described in the USP. Protect from light.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLARITHROMYCIN- CLARITHROMYCIN TABLET
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLARITHROMYCIN
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CLARITHROMYCIN
TABLETS.
CLARITHROMYCIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Contraindications (4)
05/2023
Drug Interactions (7)
05/2023
INDICATIONS AND USAGE
Clarithromycin is a macrolide antimicrobial indicated for mild to
moderate infections caused by
designated, susceptible bacteria in the following:
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Limitations of Use
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin
tablets and other antibacterial drugs, clarithromycin tablets should
be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria. (1.9)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1)
Acute Maxillary Sinusitis (1.2)
Community-Acquired Pneumonia (1.3)
Pharyngitis/Tonsillitis (1.4)
Uncomplicated Skin and Skin Structure Infections (1.5)
Acute Otitis Media in Pediatric Patients (1.6)
Treatment and Prophylaxis of Disseminated Mycobacterial Infections
(1.7)
_Helicobacter pylori_ Infection and Duodenal Ulcer Disease in Adults
(1.8)
Adults: clarithromycin tablets 250 mg or 500 mg every 12 hours for 7
to 14 days (2.2)
_H. pylori_ eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin, or
omeprazole): clarithromycin tablets 500 mg every 8 or 12 hours for 10
to 14 days. See full prescribing
information (FPI) for additional information. (2.3)
Pediatric Patients: clarithromycin 15 mg/kg/day divided every 12 hours
for 10 days (2.4)
Mycobacterial Infections: clarithromycin tablets 500 mg every 12
hours; clarithromycin tablets 7.5
mg/kg up to 500 mg every 12 hours in pediatric patients (2.5)